Multi-Country Observational Study to Collect the Frequency of Sexual Dysfunction With Antidepressant Treatment, Either With SSRIs or Duals at 8 Weeks and 6 Months

Completed

• Conditions: Major Depressive Disorder
• Interventions: Drug: SSRIs; Drug: Dual antidepressants

• Registration Number: NCT00561509
• Lead Sponsor: Eli Lilly and Company

Brief Summary

In usual clinical conditions, depressed patients with no sexual dysfunction, after signing their consent for the dissemination of their clinical information will begin their treatment with any SSRI or a Dual antidepressant as per the best clinical decision of their treating psychiatrist. Sexual dysfunction will be identified along the 6 months of active observation. Psychiatrists will decide to change dose, augment, shift or combine antidepressants at their clinical discretion in the benefit of their patients and all clinical decisions will be recorded.Comparisons among antidepressants will be made in terms of their sexual dysfunction potentiality.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2007-11-19
• Study First Submitted QC: 2007-11-19
• Study First Posted: 2007-11-21
• Study Completion: 2009-06
• Status Verified: 2009-07
• Last Update Submitted: 2009-07-13
• Last Update Posted: 2009-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1626

Inclusion Criteria

• Meet the criteria for MDD, as defined by the ICD-10 or DSM-IV-TR
• Are at least moderately depressed (baseline CGI-S less than or equal to 4)
• Provide written consent to the release of their data after being informed about the study
• Present with an episode of MDD (current, new or first episode) within the normal course of care, and agree to initiate antidepressant therapy with any available SSRI or SNRI class of antidepressant in accordance with the investigator's decision for the management of the patient
• Have been sexually active in the week prior to enrollment, either with a partner or autoerotic activity

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Exclusion Criteria

• Meet any of the following criteria for sexual dysfunction at study entry (McGahuey et all. 2000: ASEX total score less than or equal 19 or ASEX score less than or equal to 5 on any item, or ASEX score less than or equal to 4 on any 3 items
• Are simultaneously participating in a different study that includes a treatment intervention and/or an investigational drug
• Have a history of treatment resistant depression (TRD) defined as a failure to respond to 2 different antidepressants from different classes after treatment at therapeutic dose for a minimum of 4 weeks
• Have any previous or current diagnosis of schizophrenia, schizophreniform, or schizoaffective disorder, bipolar disorder, dysthymia, mental retardation, or dementia
• Have received any antidepressant within 1 week prior to enrollment (1 month prior to enrollment for fluoxetine)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A	SSRIs	SSRIs
B	Dual antidepressants	Dual antidepressants

Primary Outcome Measures

Name	Time	Method
Frequency of sexual dysfunction due to treatment with either SSRIs or Dual antidepressants	8 weeks

Secondary Outcome Measures

Name	Time	Method
Disease severity	6 months
Resource Utilization	6 months
Quality of Life	6 months
Treatment Compliance	6 months
Identify factors related to sexual dysfunction	6 months
Frequency of sexual dysfunction along treatment with SSRIs or Dual antidepressants	6 months

Trial Locations

Locations (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.; 🇦🇪 Dubai, United Arab Emirates